Thousands more doses of monkeypox vaccine are expected to soon begin shipping to the U.S. after federal health officials said they had completed an inspection of the overseas plant where they were manufactured.
The update from the Food and Drug Administration comes amid soaring demand for the two-dose vaccine as thousands of people in New York City, California and other parts of the U.S. await a chance to get the shot.
More than 1.1 million doses of the vaccine purchased by the U.S. government are currently at Bavarian Nordic's facility in Denmark. The company said earlier this week it needed authorization from an on-site FDA inspection before it could ship them to the U.S.
An FDA spokeswoman said late Wednesday that regulators “expedited and completed an inspection of the company's plant.”
“We do not expect any delay in vaccine availability due to this process,” she said in an emailed statement.
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Bavarian Nordic has already shipped 300,000 vaccine doses that were made at a third-party facility that had previously been authorized by the FDA.
The FDA requires prior inspections of all vaccine plants to assure their safety, sterility and consistency of production. A company spokesman said Bavarian Nordic sped up its plans to undergo the inspection after monkeypox began spreading in Europe in May. Initially the company planned to submit its paperwork to the FDA in August for an inspection later in the fall.
Bavarian Nordic's two-shot Jynneos is one of two vaccines that can be given in the U.S. to prevent monkeypox. The government has many more doses of an older smallpox vaccine — ACAM2000 — that can also be used, but it is considered to have a greater risk of side effects and is not recommended for people who have HIV. So it’s the Jynneos vaccine that officials have been using as a primary weapon against the outbreak.
Most monkeypox patients experience only fever, body aches, chills and fatigue. People with more serious illness may develop a rash and lesions on the face and hands that can spread to other parts of the body.
Most of the roughly 1,000 cases reported in the U.S. have been among men who have sex with men, but health officials stress that anyone can get the disease. The current number of U.S. cases reported is likely an undercount because testing is still ramping up.
White House officials have promised more supplies, chiefly from the more than 1 million-dose Bavarian Nordic stockpile. The U.S. has ordered another 2.5 million doses for delivery later this year or early next.
Last month, New York-based activists blasted the FDA for not moving more swiftly to inspect the company's plant and begin shipping the vaccines to the U.S. In a letter to the White House, the HIV non-profit PrEP4All noted that European regulators had signed off on the plant last year.
While the FDA relies on inspections by foreign regulators to review some facilities, the FDA said it conducts its own inspections for vaccines “to ensure consistency in the inspection process."
